An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Renal Anemia
17 novembre 2015 aggiornato da: Hoffmann-La Roche
Non-interventional Study to Investigate Hemoglobin Levels and Dose Over Time in the Daily Use of Mircera for Renal Anemia in Larger Centers, and to Detect Differences Between Standard of Care in the Centers
This observational study will investigate hemoglobin levels and Mircera (methoxy polyethyleneglycol-epoetin beta) dose over time in patients with chronic kidney disease, and compare standards of care between centers.
Data from each patient will be collected over 12 months of Mircera therapy.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Osservativo
Iscrizione (Effettivo)
1580
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Saarlouis, Germania, 66740
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione di probabilità
Popolazione di studio
CKD patients treated with Mirecera at different medical centers
Descrizione
Inclusion Criteria:
- adult patients, >/= 18 years of age
- chronic kidney disease
- informed consent for data transmission
Exclusion Criteria:
- serious hematological or infectious disease
- acute bleeding in the 16 weeks preceding data collection
- participation in an interventional trial
- female patients: pregnancy or breast-feeding
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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1
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As prescribed by physician
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range
Lasso di tempo: Month 0 to Month 12
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Mean hemoglobin was calculated from measurements taken during the Evaluation Period (Month 0 to Month 12).
The target hemoglobin range was 10 to 13 gram/deciliter (g/dL).
Percentage of participants with at least one hemoglobin value less than (<) 10 g/dL or greater than (>) 13 g/dL during the evaluation period by predialysis/hemodialysis is presented.
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Month 0 to Month 12
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Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size
Lasso di tempo: Month 0 to Month 12
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The percentage of participants with hemoglobin (Hb) values within the pre-defined ranges (10-12 g/dL, 11-12 g/dL, and 11-13 g/dL) during evaluation period (Month 0 to Month 12) by dose modification (yes or no), age (<65 years, greater than or equal to [>=] 65 years) and center size (>100 participants, less than or equal to [<=] 100 participants) is presented.
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Month 0 to Month 12
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Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size
Lasso di tempo: Month 6 to Month 12
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The percentage of participants with hemoglobin values within the pre-defined ranges (10-12 g/dL, 11-12 g/dL, and 11-13 g/dL) during Month 6 to Month 12 by dose modification (yes or no), age (<65 years, >=65 years) and center size (>100 participants, <=100 participants) is presented.
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Month 6 to Month 12
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Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size
Lasso di tempo: Month 0 to Month 12
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For characterization of intra-individual fluctuations, the maximum absolute differences were derived from study period specific individual mean values.
Maximum intra-individual fluctuation of hemoglobin values by predialysis/hemodialysis, age (<65 years, >=65 years), and center size (>100 participants, <=100 participants) is presented.
Data for this outcome measure was reported for overall participants.
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Month 0 to Month 12
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Serum Ferritin Values
Lasso di tempo: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
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Serum ferritin levels were measured as nanogram/milliliter (ng/mL).
Data for this outcome measure was reported for overall participants.
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Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
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Serum Iron Values
Lasso di tempo: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
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Serum iron levels were measured as microgram/deciliter (mcg/dL).
Data for this outcome measure was reported for overall participants.
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Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
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Transferrin Values
Lasso di tempo: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
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Transferrin levels were measured as milligram/deciliter (mg/dL).
Data for this outcome measure was reported for overall participants.
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Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
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Transferrin Saturation Values
Lasso di tempo: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
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Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test.
It is the ratio of serum iron and total iron-binding capacity, multiplied by 100.
Data for this outcome measure was reported for overall participants.
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Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
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C-reactive Protein (CRP) Values
Lasso di tempo: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
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The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay.
A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Data for this outcome measure was reported for overall participants.
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Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
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Number of Physicians Satisfied With Treatment at Final Visit
Lasso di tempo: Month 12 or early discontinuation
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Physicians were asked to rate their satisfaction with the methoxy polyethyleneglycol-epoetin beta treatment at final visit.
Physicians' responses were "very satisfied", "satisfied", "undecided", or "not satisfied".
One physician could analyze multiple participants but for the purpose of analysis each physician was counted as one for each analyzed participants; hence, the number of physicians (as per this assessment) was equal to the number of participants analyzed.
Data for this outcome measure was reported for overall participants.
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Month 12 or early discontinuation
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Number of Participants Who Continued Treatment With Methoxy Polyethyleneglycol-epoetin Beta After Study Completion
Lasso di tempo: Month 12 or early discontinuation
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At final visit, physicians were asked to answer ("yes" or "no") the question, whether they would continue treatment with methoxy polyethyleneglycol-epoetin beta treatment after study completion.
Data for this outcome measure was reported for overall participants.
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Month 12 or early discontinuation
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Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion
Lasso di tempo: Month 12 or early discontinuation
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At final visit, physicians were asked to state the reasons in case of discontinuation of treatment with methoxy polyethyleneglycol-epoetin beta.
The same participant could have discontinued treatment due to multiple reasons.
Data for this outcome measure was reported for overall participants.
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Month 12 or early discontinuation
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Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy
Lasso di tempo: Month 12 or early discontinuation
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Number of participants who switched to other ESA therapies including Aranesp, Biopoin, Biosimilar, Erypo, and NeoRecormon is presented.
Data for this outcome measure was reported for overall participants.
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Month 12 or early discontinuation
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Number of Participants Satisfied With Treatment at Final Visit
Lasso di tempo: Month 12 or early discontinuation
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Participants were asked to rate their satisfaction with methoxy polyethyleneglycol-epoetin beta treatment at final visit.
Participants' responses were "very satisfied", "satisfied", "undecided", or "not satisfied".
Data for this outcome measure was reported for overall participants.
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Month 12 or early discontinuation
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Lasso di tempo: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
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Average methoxy polyethylene glycol-epoetin beta dose per application is presented by study month.
Mean values were taken when more than 1 application was documented for a participant during the time period considered.
Data for this outcome measure was reported for overall participants.
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Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 marzo 2010
Completamento primario (Effettivo)
1 febbraio 2013
Completamento dello studio (Effettivo)
1 febbraio 2013
Date di iscrizione allo studio
Primo inviato
15 gennaio 2010
Primo inviato che soddisfa i criteri di controllo qualità
15 gennaio 2010
Primo Inserito (Stima)
18 gennaio 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
18 dicembre 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
17 novembre 2015
Ultimo verificato
1 novembre 2015
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ML22714
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .